An observational study in Postoperative Heart Insufficiency, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-28.
Sponsored by Charite University, Berlin, Germany · Observational
Compromised tissue oxygenation during surgery may negatively influence patient outcome. Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative pericardia effusion and/or tamponade may further compromise cardiac function. Today, hemodynamically instable patients are often monitored by means of pulmonal artery catheters or transpulmonary thermodilution. However, these methods only allow quantification of functional limitations. Underlying causes may be investigated by relatively recent technology through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that also provide the possibility of continuous monitoring. It has been reported that a training program consisting of six hours may enable physicians who are unexperienced in the field of echocardiography to apply this new method. Up to now, there is no evidence whether this methods is associated with improved postoperative outcome.
Therefore we hypothesize that continuous hemodynamically focussed transesophageal echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its application may decrease hospital expenses (secondary hypothesis).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 36 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing cardiac surgery followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital
Exclusion Criteria:
Patients monitored with hemodynamically focussed transesophageal echocardiography (placement within 12 hours of ICU admission)
Patients receiving conventional monitoring (e.g. transpulmonary thermodilution)
Cumulative dosage of catecholamine application
Time frame: three days beginning upon placement of device
degree and duration of other vasoactive substances
i.e. epinephrine, levosimendan, dopamine, nitroglycerine, nitroprusside
Time frame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
fluid balance
Time frame: day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
degree and duration of lactate acidosis
maximum lactate level, date/time of maximum lactate level, first date/time when lactate \<20
Time frame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
duration of postoperative ventilation
Time frame: first postoperative day until extubation (2 days on average)
incidence of renal failure
analysis of creatinine plasma level
Time frame: three days beginning upon placement of device (or icu admission in control patients, respectively)
incidence of hemodialysis
Time frame: three days beginning upon placement of device (or icu admission in control patients, respectively)
length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
in-hospital mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
cost of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany